Patents whose numbers are in italics have been extended under 35 USC 156. Unless otherwise noted, all expiration dates include applicable Sec. 156 and pediatric (PED) extensions.Products tagged as [GENERIC] have had a generic equivalent approved for at least one strength of the product.

Pat. No. 9375498DP* Process for the preparation of complexes of .sup.68GaClaim Types: Kit; Product-by-process; Drug in a container; Process

Aug 10, 2032

Exclusivity

Expiration

Exclusivity Description

Exclusivity Code: NCE - New chemical entity

Jun 1, 2021

Exclusivity Code: ODE - Orphan drug exclusivity

Jun 1, 2023

ODE-120: For use after radiolabeling with Ga 68, with positron emission tomography (PET) for localization of somatostatin receptor positive neuroendocrine tumors (NETs) in adult and pediatric patients.

Pat. No. 6469035 Methods of pretreating hyperlipidemic individuals with a flush inhibiting agent prior to the start of single daily dose nicotinic acid therapy to reduce flushing provoked by nicotinic acidClaim Types: Method of use

Mar 15, 2018

U-1142: Treatment of primary and mixed dyslipidemia by dosing once per day in the evening or at night, with pretreatment with a flush inhibiting agent such as aspirinU-1143: Reduction in risk of recurrent nonfatal myocardial infarction by dosing once per day in the evening or at night, with pretreatment with a flush inhibiting agent such as aspirinU-1144: Reduction in elevated TC and LDL-C by dosing once per day in the evening or at night, with pretreatment with a flush inhibitin agent such as aspirinU-1145: Reduction in TG by dosing once per day in the evening or at night, with pretreatment with a flush inhibiting agent such as aspirinU-768: A method of reducing the capacity of extended release nicotinic acid to provoke a flushing reaction by pretreating an individual with a flush inhibiting agent prior to the administration of the extended release nicotinic acid

ODE-125: Indicated in pediatric patients 10 years and older for the prevention and treatment of secondary hyperparathyroidism associated with chronic kidney disease (CKD) stages 3 and 4 and ckd stage 5 in patients on hemodialysis or peritoneal dialysis

Pat. No. 9044480 Compositions and methods for treating HCVClaim Types: Method of use

Apr 10, 2031

U-1638: Treatment of HCV infection using paritaprevir

Exclusivity

Expiration

Exclusivity Description

Exclusivity Code: I - New Indication

Jul 24, 2018

I-743: Information added to the labeling for the addition of the treatment of chronic hepatitis C virus (HCV) genotype 4 (GT4) infected patients with compensated cirrhosis based on results from study M11-665

Pat. No. 9174982 Apoptosis-inducing agents for the treatment of cancer and immune and autoimmune diseasesClaim Types: Method of use

May 26, 2030

U-1835: Treatment of patients with chronic lymphocytic leukemia (CLL) with 17p deletion, as detected by an FDA approved test, who have received at least one prior therapyU-2323: Treatment of patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), with or without 17p deletion, who have received at least one prior therapy

Exclusivity

Expiration

Exclusivity Description

Exclusivity Code: I - New Indication

Jun 8, 2021

I-782: Revisions to indication for the treatment of patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), with or without 17p deletion, who have received at least one prior therapy

Exclusivity Code: M - Miscellaneous

Jun 8, 2021

M-228: Information added to the package insert regarding the revision of the monotherapy indication of venetoclax

Exclusivity Code: NCE - New chemical entity

Apr 11, 2021

Exclusivity Code: ODE - Orphan drug exclusivity

Apr 11, 2023

ODE-114: Treatment of patients with chronic lymphocytic leukemia (CLL) with 17p deletion, as detected by an FDA approved test, who have received at least one prior therapy

ODE-161: Treatment of pulmonary arterial hypertension (PAH) (WHO group 1) in pediatric patients aged 3 yrs and older with idiopathic or congenital pah to improve pulmonary vascular resistance (PVR), which is expected to result in an improvement in exercise ability

U-1445: Method of treating pulmonary arterial hypertension by administering a pharmaceutical composition comprising macitentan and a polysorbate, wherein the polysorbate represents 0.1 to 1% of the weight of said pharmaceutical composition

U-1820: Method of treating pulmonary arterial hypertension by administering a pharmaceutical composition comprising macitentan and a polysorbate, wherein the polysorbate represents 0.1 to 3% of the weight of said pharmaceutical composition

ODE-106: For use of UPTRAVI (selexipag) tablets, 200, 400, 600, 800, 1000, 1200, 1400, and 1600 mcg for treatment of pulmonary arterial hypertension (pah, who group i) to reduce the risks of disease progression and hospitalization for pah

U-2224: Treatment of dyskinesia and increasing on time without troublesome dyskinesia in patients with Parkinson's Disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications

Exclusivity

Expiration

Exclusivity Description

Exclusivity Code: I - New Indication

Aug 24, 2020

I-769: Treatment of dyskinesia in patients with parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications

Exclusivity Code: ODE - Orphan drug exclusivity

Aug 24, 2024

ODE-153: Treatment of dyskinesia in patients with parkinson's disease receiving levodopa-based therapy with or without concomitant dopaminergic medications

ODE-177: To reduce the frequency of painful crises and to reduce the need for blood transfusions in pediatric patients, 2 years of age and older, with sickle cell anemia with recurrent moderate to severe painful crisis

I-747: For reducing the risk of graft rejection when used with high-dose busulfan and cyclophosphamide as a preparative regimen for allogeneic hematopoietic progenitor (stem) cell transplantation for pediatric patients with class 3 beta-thalassemia

Exclusivity Code: ODE - Orphan drug exclusivity

Jan 26, 2024

ODE-129: Indicated for reducing the risk of graft rejection when used in conjunction with high-dose busulfan & cyclophosphamide as a preparative regimen for allogenic hematopoietic progenitor cell transplantation for peds. patients with class 3 beta-thalassemia

U-849: Reduction of elevated intraocular pressure (IOP) in patients with glaucoma or ocular hypertension who require adjunctive or replacement therapy due to inadequately controlled IOP. dose is one drop of COMBIGAN in the affected eye twice daily

Pat. No. 7320976 Combination of brimonidine and timolol for topical ophthalmic useClaim Types: Method of use

Apr 19, 2022

U-849: Reduction of elevated intraocular pressure (IOP) in patients with glaucoma or ocular hypertension who require adjunctive or replacement therapy due to inadequately controlled IOP. dose is one drop of COMBIGAN in the affected eye twice daily

Pat. No. 9364489 Crystals and process of making 5-({[2-amino-3-(4-Carbamoyl-2,6-dimethyl-phenyl)-propionyl]-[1-(4-phenyl-- 1h-imidazol-2-yl)-ethyl]-amino}-methyl)-2-methoxy-benzoic acidClaim Types: Method of use

Pat. No. 9789125DP* Crystals and process of making 5-({[2-amino-3-(4-carbamoyl-2,6-dimethyl-phenyl)-propionyl]-[1-(4-phenyl-- 1H-imidazol-2-yl)-ethyl]-amino}-methyl)-2-methoxy-benzoic acidClaim Types: New polymorph, salt or hydrate; Method of use

U-318: Treatment of patients with an overactive bladder with symptoms of urinary frequency, urgency, or urge incontinence

Pat. No. 8920392 Method for treating overactive bladders and a device for storage and administration of topical oxybutynin compositionsClaim Types: Drug in a container; Method of use; Method of administration

Mar 26, 2031

U-1644: Treatment of overactive bladder by application of oxybutynin chloride gel to skin

Pat. No. 9259388 Method for treating overactive bladders and a device for storage and administration of topical oxybutynin compositionsClaim Types: Method of administration

Nov 6, 2029

U-1644: Treatment of overactive bladder by application of oxybutynin chloride gel to skin

U-932: PYLERA capsules, in combination with omeprazole are indicated for the treatment of patients with helicobacter pylori infection and duodenal ulcer disease to eradicate H. pyloriU-956: Treatment of patients with H. pylori infection and duodenal ulcer disease

M-200: Clinical information added to the use in specific populations section of the labeling.

Exclusivity Code: ODE - Orphan drug exclusivity

Nov 21, 2021

ODE-78: Treatment of hypercalcemia in adult patients with primary hyperparathyroidism for whom parathyroidectomy would be indicated on the basis of serum calcium levels, but who are unable to undergo parathyroidectomy.

Exclusivity Code: ODE - Orphan drug exclusivity

Feb 25, 2018

ODE-8: Treatment of severe hypercalcemia in patients with primaryhyperparathyroidism who are unable to undergo parathyroidectomy

Pat. No. 7361649DS*DP* .beta.-crystalline form of ivabradine hydrochloride, a process for its preparation and pharmaceutical compositions containing itClaim Types: New polymorph, salt or hydrate; Process; Composition; Method of use

Apr 17, 2026

U-1694: A method for treating heart failure in a human using a crystalline form of ivabradine hydrochloride

Pat. No. 7361650DS*DP* .gamma.-crystalline form of ivabradine hydrochloride, a process for its preparation and pharmaceutical compositions containing itClaim Types: New polymorph, salt or hydrate; Process; Composition; Method of use

Apr 14, 2026

U-1694: A method for treating heart failure in a human using a crystalline form of ivabradine hydrochloride

Pat. No. 7867996DS*DP* .gamma.-crystalline form of ivabradine hydrochloride, a process for its preparation and pharmaceutical compositions containing itClaim Types: New polymorph, salt or hydrate; Method of use; Composition

Feb 22, 2026

U-1694: A method for treating heart failure in a human using a crystalline form of ivabradine hydrochloride

Pat. No. 7879842DS*DP* Beta-crystalline form of ivabradine hydrochloride, a process for its preparation and pharmaceutical compositions containing itClaim Types: New polymorph, salt or hydrate; Composition; Method of use

Feb 22, 2026

U-1694: A method for treating heart failure in a human using a crystalline form of ivabradine hydrochloride

Pat. No. 7915247 Methods of use of fenofibric acidClaim Types: Method of use

Aug 20, 2027

U-1000: Adjunctive therapy to diet in patients with hyperlipidemiasU-1059: Adjunctive therapy to diet to patients with hypertriglyceridemiaU-1061: Adjunctive therapy to diet in patients with mixed dyslipidemia

ODE-46: Improvement of neurological outcome by reducing the incidence and severity of ischemic deficits in adult patients with subarachnoid hemorrhage from ruptured intracranial berry aneurysms regardless of their post-ictus neurological condition

Pat. No. 9724297DP* Sotalol compositions and uses of the sameClaim Types: Formulation; Method of use

Aug 31, 2035

U-2096: SOTYLIZE is indicated for the maintenance of normal sinus rhythm [delay in time to recurrance of atrial fibrillation/atrial flutter (AFIB/AFL)] in patients with symptomatic AFIB/AFL who are currently in sinus rhythm

U-1283: A method of treating chronic myelogenous leukemiaU-1699: A method for treating acute lymphoblastic leukemiaU-1700: A method for treating philadelphia chromosome positive acute lymphoblastic leukemiaU-1701: A method for treating leukemia resulting from a mutation in the bcr-abl kinase domainU-836: A method for the treatment of leukemias

U-1281: The treatment of patients with metastatic castration-resistant prostate cancer who have previously received docetaxelU-1588: The treatment of patients with metastatic castration-resistant prostate cancer (CRPC).

U-2001: Use for the treatment of asthma in patients 6 years of age and olderU-2002: Use for maintenance treatment of chronic obstructive pulmonary diseaseU-2122: Use for reducing exacerbations of chronic obstructive pulmonary disease

U-2001: Use for the treatment of asthma in patients 6 years of age and olderU-2002: Use for maintenance treatment of chronic obstructive pulmonary diseaseU-2122: Use for reducing exacerbations of chronic obstructive pulmonary disease

U-2001: Use for the treatment of asthma in patients 6 years of age and olderU-2002: Use for maintenance treatment of chronic obstructive pulmonary diseaseU-2122: Use for reducing exacerbations of chronic obstructive pulmonary disease

U-2001: Use for the treatment of asthma in patients 6 years of age and olderU-2002: Use for maintenance treatment of chronic obstructive pulmonary diseaseU-2122: Use for reducing exacerbations of chronic obstructive pulmonary disease

Pat. No. 7897646 Use for budesonide and formoterolClaim Types: Method of use

Mar 9, 2019 *PED

U-2002: Use for maintenance treatment of chronic obstructive pulmonary diseaseU-2122: Use for reducing exacerbations of chronic obstructive pulmonary disease

U-2001: Use for the treatment of asthma in patients 6 years of age and olderU-2002: Use for maintenance treatment of chronic obstructive pulmonary diseaseU-2122: Use for reducing exacerbations of chronic obstructive pulmonary disease

U-2001: Use for the treatment of asthma in patients 6 years of age and olderU-2002: Use for maintenance treatment of chronic obstructive pulmonary diseaseU-2122: Use for reducing exacerbations of chronic obstructive pulmonary disease

U-2288: Treatment of Type 2 diabetes mellitus with exenatide as an add-on to basal insulin or basil insulin plus metformin therapyU-654: Lowering plasma glucagon in a subject in need thereof, including one with Type 2 diabetes, by administering an exendin or analog, such as exendin-4

U-1313: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitusU-2154: Reducing fasting plasma glucose in a human in need thereof using a sustained-release composition containing Exendin-4U-2155: Reducing body weight in a human in need thereof using a sustained-release composition containing Exendin-4U-2156: Reducing HBA1C in a human in need thereof using a sustained-release composition containing Exendin-4

Exclusivity

Expiration

Exclusivity Description

Exclusivity Code: M - Miscellaneous

Sep 24, 2018

M-162: Inclusion of efficacy and safety data to the prescribing information of BYDUREON based on study GWDE

Exclusivity Code: M - Miscellaneous

Oct 20, 2020

M-212: Information added to the labeling regarding the safety and efficacy of dapagliflozin in patients with Type 2 diabetes who have inadequate glycemic control on a background combination of metformin and exenatide extended release

Exclusivity Code: M - Miscellaneous

Apr 2, 2021

M-224: Information added to the labeling regarding the safety and efficacy of exenatide extended release as add-on in patients with Type 2 diabetes who have inadequate glycemic control on basal insulin glargine with or without metformin

U-1313: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitusU-2154: Reducing fasting plasma glucose in a human in need thereof using a sustained-release composition containing Exendin-4U-2155: Reducing body weight in a human in need thereof using a sustained-release composition containing Exendin-4U-2156: Reducing HBA1C in a human in need thereof using a sustained-release composition containing Exendin-4

U-1313: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitusU-2157: Treating Type 2 diabetes mellitus by stimulating insulin releaseU-2158: Decreasing gastric motility or delaying gastric emptying by using a sustained-release composition

U-1313: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitusU-2154: Reducing fasting plasma glucose in a human in need thereof using a sustained-release composition containing Exendin-4U-2155: Reducing body weight in a human in need thereof using a sustained-release composition containing Exendin-4U-2156: Reducing HBA1C in a human in need thereof using a sustained-release composition containing Exendin-4

U-2288: Treatment of Type 2 diabetes mellitus with exenatide as an add-on to basal insulin or basil insulin plus metformin therapyU-654: Lowering plasma glucagon in a subject in need thereof, including one with Type 2 diabetes, by administering an exendin or analog, such as exendin-4

U-1313: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitusU-2154: Reducing fasting plasma glucose in a human in need thereof using a sustained-release composition containing Exendin-4U-2155: Reducing body weight in a human in need thereof using a sustained-release composition containing Exendin-4U-2156: Reducing HBA1C in a human in need thereof using a sustained-release composition containing Exendin-4

Exclusivity

Expiration

Exclusivity Description

Exclusivity Code: M - Miscellaneous

Apr 2, 2021

M-224: Information added to the labeling regarding the safety and efficacy of exenatide extended release as add-on in patients with Type 2 diabetes who have inadequate glycemic control on basal insulin glargine with or without metformin

Pat. No. 6956026 Use of exendins for the reduction of food intakeClaim Types: Method of use

Jan 7, 2018

U-1074: Use of exenatide may result in reduction in body weightU-1623: Use of exenatide may result in reduction in appetite.U-687: Reducing food intake in a subject with Type 2 diabetes by administering an exendin, such as exendin-4

Pat. No. 7741269 Exendins and exendin agonists for weight reduction and obesityClaim Types: Method of use

Jan 7, 2018

U-1074: Use of exenatide may result in reduction in body weightU-1108: Treating Type 2 diabetes mellitus with exenatide by stimulating insulin releaseU-653: Stimulating insulin release by administering exenatide

U-2139: Treatment of Type 2 diabetes mellitus in combination with exenatideU-2212: Reducing fasting plasma glucose in a human in need thereof in combination with a sustained-release composition containing exendin-4U-2213: Reducing HBA1C in a human in need thereof in combination with a sustained-release composition containing exendin-4

M-157: Information added to the labeling regarding the safety and efficacy of dapagliflozin 10mg once daily in patients with Type 2 diabetes who have inadequate glycemic control on a background combination of metformin and sulfonylurea

Exclusivity Code: M - Miscellaneous

Oct 20, 2020

M-212: Information added to the labeling regarding the safety and efficacy of dapagliflozin in patients with Type 2 diabetes who have inadequate glycemic control on a background combination of metformin and exenatide extended release

U-1097: Adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus when treatment with both saxagliptin and metformin is appropriateU-1838: Method for treating type ii diabetes mellitus by administering saxagliptin in combination with metformin

Exclusivity

Expiration

Exclusivity Description

Exclusivity Code: M - Miscellaneous

Apr 5, 2019

M-175: Information added to the labeling describing savor, a phase IV trial evaluating the effect of saxagliptin on the incidence of cardiovascular death, myocardial infarction or ischaemic stroke in patients with Type 2 diabetes

U-1097: Adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus when treatment with both saxagliptin and metformin is appropriateU-1838: Method for treating type ii diabetes mellitus by administering saxagliptin in combination with metformin

Exclusivity

Expiration

Exclusivity Description

Exclusivity Code: M - Miscellaneous

Apr 5, 2019

M-175: Information added to the labeling describing savor, a phase IV trial evaluating the effect of saxagliptin on the incidence of cardiovascular death, myocardial infarction or ischaemic stroke in patients with Type 2 diabetes

M-175: Information added to the labeling describing savor, a phase IV trial evaluating the effect of saxagliptin on the incidence of cardiovascular death, myocardial infarction or ischaemic stroke in patients with Type 2 diabetes

U-1976: Method for treating Type 2 diabetes mellitus (T2DM) in patients who have inadequate control with dapagliflozinU-1977: Method for treating Type 2 diabetes mellitus (T2DM) in patients who are already treated with dapagliflozin and saxagliptin

U-1976: Method for treating Type 2 diabetes mellitus (T2DM) in patients who have inadequate control with dapagliflozinU-1977: Method for treating Type 2 diabetes mellitus (T2DM) in patients who are already treated with dapagliflozin and saxagliptin

U-1976: Method for treating Type 2 diabetes mellitus (T2DM) in patients who have inadequate control with dapagliflozinU-1977: Method for treating Type 2 diabetes mellitus (T2DM) in patients who are already treated with dapagliflozin and saxagliptin

U-1976: Method for treating Type 2 diabetes mellitus (T2DM) in patients who have inadequate control with dapagliflozinU-1977: Method for treating Type 2 diabetes mellitus (T2DM) in patients who are already treated with dapagliflozin and saxagliptin

U-1976: Method for treating Type 2 diabetes mellitus (T2DM) in patients who have inadequate control with dapagliflozinU-1977: Method for treating Type 2 diabetes mellitus (T2DM) in patients who are already treated with dapagliflozin and saxagliptin

U-1976: Method for treating Type 2 diabetes mellitus (T2DM) in patients who have inadequate control with dapagliflozinU-1977: Method for treating Type 2 diabetes mellitus (T2DM) in patients who are already treated with dapagliflozin and saxagliptin

U-1976: Method for treating Type 2 diabetes mellitus (T2DM) in patients who have inadequate control with dapagliflozinU-1977: Method for treating Type 2 diabetes mellitus (T2DM) in patients who are already treated with dapagliflozin and saxagliptin

Exclusivity

Expiration

Exclusivity Description

Exclusivity Code: M - Miscellaneous

Apr 5, 2019

M-175: Information added to the labeling describing savor, a phase IV trial evaluating the effect of saxagliptin on the incidence of cardiovascular death, myocardial infarction or ischaemic stroke in patients with Type 2 diabetes

U-1171: Reduction of the rate of thrombotic events in patients with acute coronary syndromeU-1860: Reduction of the rate of cardiovascular death, myocardial infarction, and stroke in patients with acute coronary syndrome or a history of myocardial infarctionU-1862: Treatment of post-myocardial infarctionU-1863: Treatment of stroke

U-1171: Reduction of the rate of thrombotic events in patients with acute coronary syndromeU-1860: Reduction of the rate of cardiovascular death, myocardial infarction, and stroke in patients with acute coronary syndrome or a history of myocardial infarctionU-1864: Treatment of myocardial infarctionU-1865: Treatment of thrombotic strokeU-1866: Treatment of stable and unstable anginaU-1867: Method of inhibiting platelet aggregation

Pat. No. 7265124DS*DP* Cristalline and amorphous form of a triazolo (4,5-D) pyridimine compoundClaim Types: New polymorph, salt or hydrate; Process; Method of use

Jul 9, 2021

U-1171: Reduction of the rate of thrombotic events in patients with acute coronary syndromeU-1860: Reduction of the rate of cardiovascular death, myocardial infarction, and stroke in patients with acute coronary syndrome or a history of myocardial infarctionU-1868: Treatment of arterial thrombotic complications selected from the group consisting of unstable angina, thrombotic or embolic stroke, transient ischaemic attacks, peripheral vascular disease and myocardial infarctionU-1869: Treatment of an arterial thrombotic complication in a patient with coronary artery, cerebrovascular or peripheral vascular disease

U-1935: Reduction of the rate of cardiovascular death, myocardial infarction, and stroke in patients with a history of myocardial infarctionU-1936: Treatment of myocardial infarction and stroke in patients with acute coronary syndrome or a history of myocardial infarctionU-1937: Treatment of myocardial infarction in patients with acute coronary syndrome or a history of myocardial infarctionU-1938: Treatment of stroke in patients with acute coronary syndrome or a history of myocardial infarction

Exclusivity

Expiration

Exclusivity Description

Exclusivity Code: I - New Indication

Sep 3, 2018

I-714: Extends the 2011 approval of BRILINTA for use beginning with ACS to use beginning more remote from myocardial infarction

U-1171: Reduction of the rate of thrombotic events in patients with acute coronary syndromeU-1860: Reduction of the rate of cardiovascular death, myocardial infarction, and stroke in patients with acute coronary syndrome or a history of myocardial infarctionU-1862: Treatment of post-myocardial infarctionU-1863: Treatment of stroke

U-1171: Reduction of the rate of thrombotic events in patients with acute coronary syndromeU-1860: Reduction of the rate of cardiovascular death, myocardial infarction, and stroke in patients with acute coronary syndrome or a history of myocardial infarctionU-1864: Treatment of myocardial infarctionU-1865: Treatment of thrombotic strokeU-1866: Treatment of stable and unstable anginaU-1867: Method of inhibiting platelet aggregation

Pat. No. 7265124DS*DP* Cristalline and amorphous form of a triazolo (4,5-D) pyridimine compoundClaim Types: New polymorph, salt or hydrate; Process; Method of use

Jul 9, 2021

U-1171: Reduction of the rate of thrombotic events in patients with acute coronary syndromeU-1860: Reduction of the rate of cardiovascular death, myocardial infarction, and stroke in patients with acute coronary syndrome or a history of myocardial infarctionU-1868: Treatment of arterial thrombotic complications selected from the group consisting of unstable angina, thrombotic or embolic stroke, transient ischaemic attacks, peripheral vascular disease and myocardial infarctionU-1869: Treatment of an arterial thrombotic complication in a patient with coronary artery, cerebrovascular or peripheral vascular disease